FDA Approved New IUD to Prevent Pregnancy
February 27, 2015 – The U.S. Food and Drug Administration (FDA) approved Liletta (levonorgestrel-releasing intrauterine system), manufactured by Actavis and Medicines360, a nonprofit women's health pharmaceutical company. Liletta is intended for use by women to prevent pregnancy for up to three years.
Liletta is an Intrauterine Device which must be inserted by a healthcare professional, and it releases levonorgestrel over a three year period. While Liletta can be removed at any time, it must be removed by the end of the third year. Liletta will be available for use by the second quarter of 2015. It will be available through a limited network of specialty distributors.
Through a partnership, Actavis and Medicine360 have created an option to prevent pregnancy that is available to women regardless of income or insurance coverage. Liletta will be available commercially and will also be available at a lower cost through public healthcare clinics enrolled in 340B drug pricing programs.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.